Brii Biosciences Provides Corporate Update and Reports Full-Year 2024 Financial Results

Strategic Acquisition of Intellectual Property of BRII-179, a Wholly Owned Phase2bAsset Capable of Combining with Multiple HBV Treatment Modalities for Cure

Data from Multiple Ongoing Late-Stage Studies Reinforce Brii Bio's HBV Functional Cure Strategy of Optimized Combination Regimens to Target Patient Populations

4 Abstracts Including 2 Oral Presentations with Data from the Ongoing Phase 2 ENSURE Study at the Upcoming APASL (March 26-30)

Strong Cash Reserves ofUS$335.7 Millionto Propel Operations into 2028

Actively Seeking Partnership Opportunities for Non-HBV Programs

Conference Call (English Session) Scheduled forMarch 31at8:30 PMHKT /8:30 AM ET

DURHAM, N.C. andBEIJING, China,March 21, 2025/PRNewswire/ --Brii Biosciences Limited ("Brii Bio,"or the"Company,"stock code: 2137.HK), a biotechnology company developing therapies to improve patient health across diseases with high unmet medical needs provided a corporate update today and reported its financial results for the year endedDecember 31, 2024.

(PRNewsfoto/Brii Biosciences Limited)

In 2024,Brii Bioadvanced its corehepatitis B virus (HBV) functional cure program, gainingvaluable data from ongoing Phase 2 trials that support its goal of achieving higher functional cure rates for patients through combined immunomodulation and surface antigen reduction approaches. These data support BRII-179 (a recombinant protein-based HBV immunotherapeutic) as a key differentiator through identifying patients who are potentially more susceptible to curative therapies. Two Phase2bstudies, ENRICH and ENHANCE, are fully enrolled to confirm these important findings. End-of-treatment (EOT) data from its ENSURE study suggests a direct role of elebsiran (an HBV-targeting siRNA) in achieving a higher HBV functional cure rate. Elebsiran is currently being evaluated in multiple ongoing trials withBrii Bio'sother assets, including ongoing trials of tobevibart (a broadly neutralizing monoclonal antibody targeting HBV) run by Vir Biotechnology, Inc. ("Vir Biotechnology,"Nasdaq: VIR). Upcoming 2025 data readouts from these studies will guideBrii Bio'slate-stage development and registration strategy.Brii Bioremains well-funded with a cash position ofUS$335.7 million, sufficient to support the Company through late-stage development plans for HBV functional cure.

"The critical milestones we achieved in 2024 have strengthened our HBV portfolio of multiple mechanisms of action at both the clinical and strategic level,"statedZhi Hong, Ph.D., Chairman and Chief Executive Officer ofBrii Bio."Data from multiple ongoing combination studies with our highly differentiated HBV assets continue to show that our multi-modal approach has the potential to produce higher functional cure rates across broader HBV patient groups. With the strategic acquisition of BRII-179 and data from three ongoing Phase2bstudies throughout this year and next, we are creating multiple curative treatment options for patients with chronic HBV infection."

Clinical Development Update

Brii Biois actively advancing its innovative product pipeline, with a primary focus on the late-stage clinical development of its flagship HBV program.

HBV Program

The Company is progressing multiple ongoing combination studies with its differentiated HBV candidates, including elebsiran, an HBV-targeting siRNA; BRII-179, a recombinant protein-based HBV immunotherapeutic. The Company's partner, Vir Biotechnology, is also progressing multiple combination studies with elebsiran and tobevibart, a broadly neutralizing monoclonal antibody targeting HBV surface antigen.

By addressing HBV from these three distinct therapeutic perspectives in varying combinations with each other,Brii Bioaims to determine the best curative regimens to address different population subsets and the most efficient regulatory path to approval. Upcoming pivotal data sets from the Company's ongoing ENRICH (BRII-179 in priming HBV-specific immunity and enriching patients with competent immunity) and ENSURE (elebsiran in combination with PEG-IFNα versus PEG-IFNα alone) studies are expected throughout 2025-2026 and will further inform late-stage studies asBrii Bioadvances toward determining HBV functional cure.

  • Brii Biocompleted enrollment in its ENHANCE study inJanuary 2025. The ENHANCE study is a Phase2b, randomized, double-blind study evaluating the clinical efficacy and safety of the combination therapy of BRII-179, elebsiran, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.
  • Brii Biopresented 48-week EOT data from its Phase 2 ENSURE study at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in a late-breaking oral presentation inNovember 2024. Data showed patients treated with elebsiran in combination with PEG-IFNα achieved a higher rate of HBV surface antigen loss (HBsAg) than patients treated with PEG-IFNα alone. The ENSURE study data marks the industry's first evidence delineating the contribution of siRNA (elebsiran) toward functional cure on top of PEG-IFNα therapy through head-to-head comparison with PEG-IFNα alone, highlighting elebsiran's potential to make a substantial impact on producing higher HBV functional cure rates.Brii Bioplans to present additional key data readouts in the first half of 2025.
  • The ENSURE study is also investigating patients with prior experience of receiving BRII-179. Based on early data from Cohort 4 of the ENSURE study (data to be released at APASL 2025), the ENRICH study was fully enrolled inNovember 2024, evaluating the role of BRII-179 in priming HBV-specific immunity as part of a curative regimen and as a tool to identify immuno-responsive patients with a higher probability of achieving functional cure.
  • Brii Bio'sdevelopment partner, Vir Biotechnology, presented data from its Phase 2MARCHandSOLSTICEstudies at AASLD's The Liver Meeting inNovember 2024.
    • Vir Biotechnology recently commenced a Phase 3 registrational clinical program (ECLIPSE) to evaluate the tobevibart and elebsiran combination in people living with chronic hepatitis delta (CHD).
    • Vir Biotechnology was granted Fast Track designation for tobevibart and elebsiran for the treatment of CHD inJune 2024by the U.S. Food and Drug Administration (FDA), followed by Orphan designation by the European Medicines Agency (EMA) inNovember 2024, and FDA Breakthrough Therapy Designation and EMA Prime Designation inDecember 2024.
  • The CDE granted Breakthrough Therapy Designations (BTD) for tobevibart and elebsiran inMay 2024.

Additional Clinical Programs

Brii Biois actively seeking external partnerships for its therapeutic candidates for HIV, MDR/XDR and central nervous system diseases.

  • InOctober 2024,Brii Bioreceived IND approval from CDE of NMPA for a Phase 1 PK bridging study inChinawith BRII-693, a novel polymyxin for the treatment of serious gram-negative infections. Previous phase 1 data has been published onAntimicrobial Agents and ChemotherapyinDecember 2024, supporting future global Phase 3 registrational trial in patients with hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.Brii Bioholds exclusive global rights to develop and commercialize BRII-693.

Full Year 2024 Corporate Highlights and Recent Update

  • In December 2024, Brii Bio announced the approval of aHK$60 millionshare-buyback program, or 10% of its total outstanding shares, underscoring the Company's confidence in its prospects. As ofMarch 21, 2025, the Company had repurchased approximately 4,433,000 shares on the Hong Kong Stock Exchange for a consideration of approximatelyHK$5.3 million.
  • In December 2024, Brii Bio signed an asset purchase agreement with VBI Vaccines, Inc. ("VBI") and its associated subsidiaries to acquire full intellectual property rights and other assets relating to BRII-179 for a total consideration of$18 million. The agreement eliminates future payments to VBI related to BRII-179 and PreHevbriTMand dissolves the prior agreement announced onFebruary 14, 2024. The purchase bringsBrii Bioadditional commercial upside while ensuring the uninterrupted clinical supply of BRII-179 as the Company continues to develop this asset with ongoing studies that support BRII-179's potential to increase HBV patients'response to curative treatments.

Full Year 2024 Financial Results

  • Our bank deposits and cash and cash equivalents wereRMB2,413.4 millionas ofDecember 31, 2024, representing a decrease of 248 million or 9.3% compared withRMB2,661.4 millionas ofDecember 31, 2023. The decrease was primarily due to payout of daily operations and research and development activities.
  • Other income wasRMB141.4 millionfor the year endedDecember 31, 2024, representing a decrease ofRMB22.3 millionor 13.6%, compared withRMB163.7 millionfor the year endedDecember 31, 2023. This was mainly due to the decrease in bank interest income ofRMB20.8 millionattributable to the declining interest rates on USD and HKD time deposits and the decrease in income recognized from PRC government grants.
  • Research and development expenses wereRMB249.8 millionfor the year endedDecember 31, 2024, representing a decrease ofRMB152.9 millionor 38.0%, compared withRMB402.7 millionfor the year endedDecember 31, 2023. The decrease was primarily attributable to the decrease in third-party contracting cost ofRMB79.3 millionand the decrease in employee cost ofRMB67.7 million, which were primarily due to pipeline prioritization and organizational optimization during the year.
  • Administrative expenses wereRMB153.2 millionfor the year endedDecember 31, 2024, representing a decrease ofRMB43.3 millionor 22.0%, compared withRMB196.5 millionfor the year endedDecember 31, 2023. The decrease was primarily attributable to the decrease in employee cost ofRMB39.7 million, which was primarily attributable to pipeline prioritization and organizational optimization during the year.
  • Loss for the year wasRMB512.4 millionfor the year endedDecember 31, 2024, representing an increase ofRMB328.0 millionor 177.9%, compared withRMB184.4 millionfor the year endedDecember 31, 2023. The increase in loss was primarily attributable to investment-related losses ofRMB126.1 millionand impairment losses ofRMB90.3 million, partially offset by the decrease in research and development expenses and administrative expenses. In contrast to the prior year, which benefited from a significant gain on the one-time sale of assets ofRMB131.8 millionand the increase in the share price of an equity investment ofRMB129.2 million, the current year was impacted by a decline in the fair value of the same equity investment.

Conference Call Information

A live conference call (English session) will be hosted onMarch 31, 2025at08:30 AMU.S. Eastern Time (8:30 PMHong Kong Time) when the management team will provide an annual update including data to be presented at the APASL conference onMarch 26-30. All participants are required to register in advance of the call. For the registration link, please clickhere.

All participants shall use the link provided above to complete the online registration process prior to the conference call. Upon registering, each participant will receive an email with important details for this call, including the call date, time and access link. This link is to be kept confidential and not shared with other participants. Additionally, a replay of the conference call will be available after the call and can be accessed by visiting the Company's website at www.briibio.com under the Investor Relations section.

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This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release.Brii Biodisclaims responsibility for such third-party information.

AboutBrii Bio

Brii Biosciences Limited ("Brii Bio,"stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, theSan Francisco Bay Area,BeijingandShanghai. For more information, visitwww.briibio.com.

Forward-Looking Statement

The information communicated in this press release contains certain statements that are or may be forward-looking. These statements typically contain words such as"will,""expects,""believes,""plans"and"anticipates,"and words of similar import. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company is unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.

 

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